The following data is part of a premarket notification filed by Andwin Scientific with the FDA for Safetex Cervical Scraper (plastic).
| Device ID | K983428 |
| 510k Number | K983428 |
| Device Name: | SAFETEX CERVICAL SCRAPER (PLASTIC) |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ANDWIN SCIENTIFIC 6636 VARIEL AVE. Canoga Park, CA 91303 |
| Contact | Natalie Sarraf |
| Correspondent | Natalie Sarraf ANDWIN SCIENTIFIC 6636 VARIEL AVE. Canoga Park, CA 91303 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1998-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00187207000269 | K983428 | 000 |
| 00187207000252 | K983428 | 000 |
| 00187207000238 | K983428 | 000 |